GENERAL DIAG. CHROMOSTRATE HEPARIN ASSAY

GENERAL DIAG. CHROMOSTRATE HEPARIN ASSAY is an FDA 510(k)-cleared medical device (K850486) manufactured by Warner-Lambert Co.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 7, 1985. Regulation: 8.